FDA.reportPublic FDA data

Bertec Vision Advantage

Primary DI
00850017250000
Brand
Bertec Vision Advantage
Company
BERTEC CORPORATION
Model
97P-0037
Device description
Bertec Vision Advantage (BVA) device is designed to measure changes in the visual acuity during head movements. It includes a laptop computer with a wireless remote controller, a wireless inertial measurement unit (IMU) that measures the 3-dimensional angles, velocities, and accelerations, and a headband. The headband holds the IMU in a small pouch, which allows tracking of the head movements. The remote controller is used to input the patient’s responses to the computer.
Published
2021-01-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HOXChart, Visual Acuity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOXChart, Visual AcuityOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850017250000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850017250000008500172500008500172500000850017250000

GMDN Terms#

Term, Definition table
TermDefinition
Dynamic visual acuity testing systemAn assembly of devices used to track changes in visual acuity during head movements primarily to quantify visual acuity loss due to vestibular pathology. The assembly typically includes a three-dimensional (3-D) integrating gyrometer (or equivalent) fastened to the patient's head, a connected personal computer used to track the patient's ability to correctly identify an image according to a specified head movement, a mounted monitor for image viewing, and operating system software. The system helps to identify patients most likely to benefit from vestibular rehabilitation exercises.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-614-543-8099support@bertec.com

Regulatory Flags#

DUNS number
619142540
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850017250017Balance Advantage Essential Spark System97P-00772021-01-05
00850017250031Balance Advantage Functional System97P-00052021-01-05
00850017250116Bertec Head Mounted Display System (HMD)97P-01092023-02-08
00850017250093Bertec Vision Trainer System (BVT)95P-001495P-00142022-01-24
00850017250024Balance Advantage Portable Functional System97P-00662021-01-05
00850017250048Balance Advantage Essential System97P-00012021-01-05
00850017250055Balance Advantage Portable essential System97P-00022021-01-05
00850017250062Balance Advantage Prime IVR System97P-00722021-01-05
00850017250079Balance Advantage Computerized Dynamic Posturography System97P-00362021-01-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971922133319YEASNChongqing Yeasn Science & Technology Co.,Ltd.HOX2026-05-01
B43050085700GoCheck KidsGobiquity, Inc.HOX2026-01-09
04987669204610Open-field Refraction SystemNIDEK CO.,LTD.HOX2026-01-08
04987669204917Open-field Refraction SystemNIDEK CO.,LTD.HOX2026-01-08
04560126269287MIRROR CHART MC-5S for COMPU VISION CV-5000TOPCON CORPORATIONHOX2025-12-09
08800019601074Visual Acuity Chart System HDC-100Huvitz Co., Ltd.HOX2025-11-19
B43071000030GoCheck MultiScreenerGobiquity, Inc.HOX2025-11-19
B43050085610GoCheck KidsGobiquity, Inc.HOX2025-11-04
B43050085600GoCheck KidsGobiquity, Inc.HOX2025-10-22
04540008310580RexxamREXXAM CO., LTD.HOX2025-10-17
04540008310610RexxamREXXAM CO., LTD.HOX2025-10-17
00812559012003NearBrightREICHERT, INC.HOX2025-08-12
00812559012010NearBrightREICHERT, INC.HOX2025-08-12
00812559012201ClearChart4REICHERT, INC.HOX2025-08-12
00812559012225ClearChart4XREICHERT, INC.HOX2025-08-12
00812559012232ClearChart4PREICHERT, INC.HOX2025-08-12
B43050085500GoCheck KidsGobiquity, Inc.HOX2025-03-20
08034028770562TOPCONVISIA IMAGING SRLHOX2025-02-20
B43071000020GoCheck MultiScreenerGobiquity, Inc.HOX2024-09-23
06971922133234YEASNChongqing Yeasn Science & Technology Co.,Ltd.HOX2024-08-08
B43050085440GoCheck KidsGobiquity, Inc.HOX2024-07-26
B43071000010GoCheck KidsGobiquity, Inc.HOX2024-07-26
08800074500008Visual Chart SystemVIEW-M TECHNOLOGY CO., LTD.HOX2024-03-25
08800074500015Visual Chart SystemVIEW-M TECHNOLOGY CO., LTD.HOX2024-03-25
08800074500022Visual Chart SystemVIEW-M TECHNOLOGY CO., LTD.HOX2024-03-25
08800074500039Visual Chart SystemVIEW-M TECHNOLOGY CO., LTD.HOX2024-03-25
08800074500114Visual Chart SystemVIEW-M TECHNOLOGY CO., LTD.HOX2024-03-25
08800074500190Self Vision TesterVIEW-M TECHNOLOGY CO., LTD.HOX2024-03-25
08800074500213Self Vision TesterVIEW-M TECHNOLOGY CO., LTD.HOX2024-03-25
08800074500282Visual Chart SystemVIEW-M TECHNOLOGY CO., LTD.HOX2024-03-25